In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., Novartis scored another obviousness-type double patenting (OTDP) win when the Federal Circuit held that a post-URAA child patent could not be cited as an OTDP reference against a pre-URAA parent patent having the same priority date, and upheld the validity of an Orange Book-listed patent for Novartis’s Zortress® and Afinitor® products. This decision was issued the same day the Federal Circuit held that a patent term extension award does not itself raise OTDP issues, upholding the validity of Novartis’s Galenya® product patent.

The Novartis Patents At Issue

This decision arose from ANDA litigation relating to Novartis’s Zortress® and Afinitor® products, which are indicated for treating cancer and preventing kidney and liver transplant rejection. The asserted/challenged patent was U.S. Patent No. 5,665,772, a pre-GATT/pre-URAA patent having a term of 17 years from its issue date. Novartis obtained a 5 year patent term extension (PTE) of the ‘772 patent under 35 USC 156, based on FDA approval of Afinitor®.

(image from Federal Circuit decision)

The other patent discussed in this case was Novartis’s U.S. Patent No. 6,440,990, which was a post-GATT/post-URAA child of the ‘772 patent, filed and granted after the ‘772 patent, but expiring earlier.

The district court considered the 2014 Federal Circuit decision in Gilead Sciences, Inc. v. Natco Pharma Ltd., and determined that the ‘990 patent could be cited as an OTDP reference against the ‘772 patent. The parties stipulated to invalidity on that basis, so the district court held the asserted claims of the ’772 patent invalid.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Chen and joined by Chief Judge Prost and Judge Wallach. As noted above, the Federal Circuit held that the post-GATT/post-URAA ‘990 patent could notbe cited as an OTDP reference against the pre-GATT/-preURAA ‘772 patent.

Gilead Is Not Controlling

The Federal Circuit first explained that the holding in Gilead–that “the expiration date is the benchmark of obviousness-type double patenting”–is “limited to the context of when both patents in question are post-URAA patents.” Because the case at hand involved “one pre-URAA patent (the ’772 patent) and one post-URAA patent (the ’990 patent), governed by different patent term statutory regimes,” Gilead is not controlling. The Federal Circuit explained that the potential for gamesmanship discussed in Gilead did not arise here, “because the ’772 patent expires after the ’990 patent only due to happenstance of an intervening change in patent term law.” The Federal Circuit also noted that, “unlike Gilead, Novartis here did not structure the priority claim of its ’990 patent to capture additional patent term” beyond the ’772 patent–to the contrary, the ’990 patent expired earlier.

“Traditional” OTDP Doctrine Is Controlling

Having dispensed with recent decisions addressing post-GATT/post-URAA patents, the Federal Circuit determined that “traditional” OTDP doctrine is controlling when a post-URAA patent is cited as an OTDP reference against a pre-URAA patent. Under “traditional” OTDP doctrine, the inquiry focuses on double patenting that may have existed as of the challenged patent’s issue date. Under such an analysis, “the ’990 patent is not a proper [OTDP] reference for the ’772 patent.” because “the ’990 patent had not yet issued” when the ’772 patent was issued.

Giving Full Effect To The Statutorily Granted Term

The Federal Circuit noted that its approach here is consistent with the URAA transition statute, which ensured that existing patent owners and applicants only would benefitfrom the change in patent term. Under the URAA transition statute, the term of any patent in force on or granted from an application filed before June 8, 1995 was “the greater ofthe 20-year term … or 17 years from grant, subject to any terminal disclaimers.” According to the Federal Circuit, “to require patent holders to truncate any portion of the statutorily-assigned term of a pre-URAA patent that extends beyond the term of a post-URAA patent would be inconsistent with the URAA transition statute.”

The Federal Circuit also found its approach to be “consistent with the core principle underlying the double patenting doctrine: giving one invention and nonobvious variants of that invention the same patent term.” The decision explains:

Here, critically, Novartis did not seek to extend its patent rights over its everolimus invention beyond one patent term, in this case, 17 years from issuance of the ’772 patent. …. The fact that the law for the term of a patent changed resulting in the later-issued ’990 patent having an earlier expiration date than it would have pre-URAA should not affect the ’772 patent’s statutorily-granted 17-year patent term. Rather than Novartis receiving a windfall with a 17-year term for its ’772 patent, its ’990 patent’s term was truncated by the intervening change in law. To find that obviousness-type double patenting applies here because a post-URAA patent expires earlier would abrogate Novartis’s right to enjoy one full patent term on its invention.

The court therefore reversed the district court decision.

What About Patent Term Adjustment?

While facts at issue in this decision are not as parallel to the PTA scenario I discussed in my article on the Galenya® decision, the Federal Circuit’s willingness to consider whether the patents at issue have the same priority date, and whether the fact pattern could give rise to gamesmanship leaves room for a decision that would not permit a child application to be cited as an OTDP reference against a parent patent that expires later due to a PTA award. Indeed, PTA only is awarded where the USPTO’s examination delay exceeded any “delay” by the Applicant, reducing the opportunity for gamesmanship. Perhaps this panel of Federal Circuit judges also would permit a first-filed patent to enjoy the full benefit the additional term granted pursuant to the PTA statute.

In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the Novartis Gilenya patent, the court confirmed that the statute permits an extended product patent to “effectively” block the practice of an earlier-expiring method patent, and refused to elevate the judicially-created doctrine of obviousness-type double patenting over the statutory grant of PTE. Pharmaceutical patent owners will welcome this decision as reinforcing the validity of patents during their PTE term, and may consider how it might apply to similar circumstances raised by a patent term adjustment (PTA) award.

The Novartis Gilenya Patents At Issue

This decision arose from ANDA litigation relating to Novartis’s Gilenya® product for treating multiple sclerosis. The asserted/challenged patent was U.S. Patent No. 5,604,229, which claims the active ingredient in Gilenya® (fingolimod). The ‘229 patent is a pre-GATT/pre-URAA patent having a term of 17 years from its issue date. Novartis obtained a 5 year patent term extension (PTE) of the ‘229 patent under 35 USC 156, based on FDA approval of Gilenya®.

(image from Federal Circuit decision)

The other patent discussed in this case was Novartis’s U.S. Patent No. 6,004,565, which claims therapeutic methods using fingolimod. The ‘565 patent was a post-GATT/post-URAA patent having a term of 20 years from its filing date.

The District Court Decision

At the district court, Ezra sought a motion for judgment on the pleadings based on invalidity of the ‘229 patent, asserting that the PTE award should not have extended the term of the ‘229 patent beyond the expiration date of the ‘565 patent. In particular Ezra argued that the PTE award:

“de facto extends the life of the ’565 patent, and thereby violates § 156(c)(4)’s requirement that only “one patent be extended”

“renders the ’229 patent invalid for statutory- and obviousness-type double patenting” in view of the claims of the ‘565 patent

“violates the ‘bedrock principle’ that the public may practice an expired patent”

The district court denied the motion.

Ezra stipulated that its ANDA product infringed the ’229 patent, and the district court found the ‘229 patent “valid, unexpired, and enforceable,” and issued an injunction against Ezra’s ANDA product until the ‘229 patent expires in 2019.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Chen and joined by Judges Moore and Hughes. The decision addressed each of Ezra’s arguments.

(1) No Violation of § 156(c)(4)

The Federal Circuit agreed with the district court that the PTE award did not violate § 156(c)(4), which holds that only one patent may be granted PTE. Ezra argued that the PTE award to the ‘229 product patent “effectively” extended the term of the ‘565 method of use patent, since the claimed methods could not be practiced without using the product claimed in the ‘229 patent. Both courts declined to read the term “effectively” into the statutory language, and the Federal Circuit emphasized that “only the ’229 patent was selected and then legally extended” in accordance with 35 U.S.C. § 156(e)(1). The court emphasized:

That the method of the ’565 patent cannot be practiced during the ’229 patent’s extended term is a permissible consequence of the legal status conferred upon the ’229 patent by § 156.

(2) no violation of the doctrine of obviousness-type double patenting

Both the district court and the Federal Circuit cited the 2007 Federal Circuit decision in Merck & Co. v. Hi-Tech Pharmacal Co., as permitting the full PTE award here. In Merck, the Federal Circuit held that “a patent term extension under § 156 may be applied to a patent subject to a terminal disclaimer.” As noted by the district court here, in such a case the term of the PTE-extended patent “necessarily will expire after the patent” over which it was terminally disclaimed. Thus, both the district court and the Federal Circuit found that Merck permits a fact-pattern similar to that at issue here, where PTE extends the term of one patent beyond the term of another patent that may raise obviousness-type double patenting issues.

In this regard, the Federal Circuit decision draws a bright line delineating whendouble patenting issues can arise:

If a patent, under its original expiration date without a PTE, should have been (but was not) terminally disclaimed because of obviousness-type double patenting, then this court’s obviousness-type double patenting case law would apply, and the patent could be invalidated. However, if a patent, under its pre-PTE expiration date, is valid under all other provisions of law, then it is entitled to the full term of its PTE.

(3) no overriding policy concerns

The Federal Circuit also addressed Ezra’s policy arguments, drawing an interesting line between “traditional” obviousness-type double patenting concerns and those addressed in its 2014 decision in Gilead Sciences, Inc. v. Natco Pharma Ltd.

As to “traditional” concerns, the Federal Circuit noted:

This case does not raise the traditional concern with obviousness-type double patenting of a patent owner “extending his exclusive rights to an invention through claims in a later-filed patent that are not patentably distinct from claims in the earlier filed patent.” …. Here, it is the earlier-filed, earlier-issued ’229 patent … that has the later expiration date, due to a statutorily-allowed
term extension under § 156.

As to Gilead, the Federal Circuit found “no potential gamesmanship issue through structuring of priority claims as identified in Gilead.” Rather, “[b]ut for the § 156 PTE, the ’229 patent would have expired before the ’565 patent.” Also, “there is also no concern that Novartis, once its ’229 patent issued, sought to subsequently “secur[e] a second, later expiring patent for the same invention” as in AbbVie, Inc. v. Mathilda & Terence Kennedy Institute of Rheumatology Trust.

Thus, the Federal Circuit held that “PTE pursuant to § 156 is valid so long as the extended patent is otherwise valid without the extension,” and affirmed the district court decision.

What About Patent Term Adjustment?

While this decision addressed PTE granted under § 156, “to restore the value of the patent term that a patent owner loses during the early years of the patent” prior to FDA approval, much of the reasoning would apply to PTA granted under § 154 to one member of a patent family sharing the same priority date to compensate for patent term lost due to USPTO examination delays.

The first member of a patent family may be awarded significant PTA, especially if the patent was granted after a successful appeal of the examiner’s rejection(s) to the USPTO Patent Trial and Appeal Board, a process that can take several years. Subsequently filed continuation applications often are examined and granted more quickly, resulting in an earlier-filed, earlier-granted patent having a longer term than its later-filed, later-granted continuations. Gilead raised concerns that PTA awarded to the first member of a patent family could be lost if continuation applications can be cited as obviousness-type double patenting references, but this decision raises the possibility that at least this panel of Federal Circuit judges would permit such a first-filed patent to enjoy the full benefit the additional term granted pursuant to the PTA statute.

Indeed, wouldn’t this same principle apply to PTA:

[T]his court has described obviousness-type double patenting as a “judge-made doctrine” that is intended to prevent extension of a patent beyond a “statutory time limit.” …. Here, agreeing with Ezra would mean that a judge-made doctrine would cut off a statutorily-authorized time extension. We decline to do so.

In Yeda Research & Development Co., v. Mylan Pharmaceuticals Inc., the Federal Circuit affirmed the decisions of the USPTO Patent Trial and Appeal Board (PTAB) finding three Copaxone patents invalid as obvious in parallel Inter Partes review (IPR) proceedings. The companion decision pertaining to related district court litigation caught my attention for its use of originally confidential statements to FDA as evidence of the state of the art that supported obviousness. This decision caught my attention for its use of a study published three weeks after the priority date as evidence of the motivation and reasonable-expectation-of-success elements of obviousness.

The COPAXONE® Patents At Issue

The Copaxone patents at issue in this case were U.S. Patent Nos. 8,232,250, 8,399,413, and 8,969,302, which are three of the five patents listed in the Orange Book for Copaxone® (glatiramer acetate) 40 mg/ml. The Federal Circuit deemed claim 1 of the ‘250 patent representative:

1. A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient a therapeutically effective regimen of three subcutaneous injectionsof a 40 mg dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, the regimen being sufficient to alleviate the symptom of the patient.

Thus, the claimed methods relate to a 3x/week dosing regimen said to be associated with reduced side effects as compared to treatment with Copaxone® 20 mg/ml administered daily.

The Not-Quite Prior Art Reference

The Federal Circuit decision was authored by Judge Reyna and joined by Judges Bryson and Stoll. The Federal Circuit reviewed the asserted prior art, and noted that it included:

an understanding that the 20 mg/ml dose had not been optimized

suggestions to explore optimal dosing

recognition that daily injections were problematic for patients

studies of alternate daily dosing of 20 mg/ml

studies of daily dosing of 40 mg/ml (including the “FORTE” study)

studies of alternate daily dosing of 40 mg/ml*

*This differs from the claimed regimens by one dose over a two week period.

The PTAB decisions also cited Khan 2009, which was published three weeks after the priority date but nevertheless deemed to be relevant to “the state of the art” because it reported a study commenced 2 years earlier.

The abstract of Kahn 2009 stated, “[t]here is considerable interest in studying a more patient friendly dosing regimen of GA that may be as efficacious and better tolerated than daily GA.” The Khan 2009 study compared 20mg GA 2x/week to 20mg GA daily.

Khan 2009 was cited in the IPRs in the reply declaration of Mylan’s expert, in support of his testimony that a person of ordinary skill in the art would have been motivated to explore less frequent dosing regimens than the original daily dosing. As noted in the Federal Circuit decision, the PTAB “found Khan 2009 probative of the fact that POSITAs were motivated to investigate dosing regimens of GA with fewer injections to improve patient compliance.”

The PTAB cited Khan 2009 in support of the following:

[T]he study in Khan 2009 commenced nearly two years before the priority date of the ’250 patent. We, therefore, find that Khan 2009 is probative of the fact that those skilled in the art were motivated to investigate dosing regimens of GA with fewer injections to improve patient compliance.

[N]early two years before the priority date of the ’250 patent, Khan 2009 commenced its study on 20 mg GA administered twice-a-week, further evincing that an ordinary artisan would have had a reasonable expectation of success in pursuing a 40 mg, three-times-weekly GA dosing regimen.

Yeda challenged the PTAB’s reliance on Khan 2009, but the Federal Circuit found the first use proper, the second “a simple oversight, constituting harmless error,” and the third use to be possibly erroneous but nevertheless harmless:

To the extent that this reliance was error, we conclude that it was harmless error. Khan 2009 was the last piece of evidence in a lengthy analysis which the Board also relied on Flechter, Khan 2008, Caon, Pinchasi, and testimony from Dr. Green in finding a POSITA would have had a reasonable expectation of success in the claimed regimen. Even if the Board’s reliance on Khan 2009 was improper, it is harmless error because substantial evidence otherwise supports the Board’s conclusion.

Why didn’t the court expressly find the third use—evidence of a reasonable expectation of success—improper?

Given that the PTAB also discussed the resultsof the Khan 2009 study and the reported conclusion “that GA administered less frequently than daily may be as efficacious and better tolerated than GA administered daily,” I have less confidence than the Federal Circuit that its use was cabined to the limited purpose of showing what persons of ordinary skill in the art understood before the priority date, e.g., when the Khan 2009 study was commenced.

]]>https://www.pharmapatentsblog.com/2018/11/13/not-quite-prior-art-supports-obviousness-of-copaxone-patents/feed/0Invalidity Of Copaxone Patents Supported By Statements To FDAhttps://www.pharmapatentsblog.com/2018/10/23/invalidity-of-copaxone-patents-supported-by-statements-to-fda/
https://www.pharmapatentsblog.com/2018/10/23/invalidity-of-copaxone-patents-supported-by-statements-to-fda/#respondTue, 23 Oct 2018 05:00:43 +0000https://www.pharmapatentsblog.com/?p=7607
In In re Copaxone Consolidated Cases, the Federal Circuit affirmed the district court decision finding four patents directed to a specific dosing regimen for using COPAXONE® 40 mg/ml to treat patients with relapsing multiple sclerosis invalid as obvious. One thing that caught my attention was the use of originally confidential statements to FDA as evidence of...… Continue reading this entry]]>

In In re Copaxone Consolidated Cases, the Federal Circuit affirmed the district court decision finding four patents directed to a specific dosing regimen for using COPAXONE® 40 mg/ml to treat patients with relapsing multiple sclerosis invalid as obvious. One thing that caught my attention was the use of originally confidential statements to FDA as evidence of the state of the art that supported the obviousness holding.

The COPAXONE® Patents At Issue

The patents at issue were U.S. Patent Nos. 8,232,250, 8,399,413, 8,969,302, and 9,155,776, which are four of the five patents listed in the Orange Book for Copaxone® (glatiramer acetate) 40 mg/ml. (The fifth patent, U.S. Patent No. 9,402,874, issued later and is the subject of separate litigation.)

The Federal Circuit deemed claim 1 of the ‘250 patent representative:

1. A method of alleviating a symptom of relapsing-remitting multiple sclerosis in a human patient suffering from relapsing-remitting multiple sclerosis or a patient who has experienced a first clinical episode and is determined to be at high risk of developing clinically definite multiple sclerosis comprising administering to the human patient a therapeutically effective regimen of three subcutaneous injectionsof a 40 mg dose of glatiramer acetate over a period of seven days with at least one day between every subcutaneous injection, the regimen being sufficient to alleviate the symptom of the patient.

Thus, the claimed methods relate to a 3x/week dosing regimen said to be associated with reduced side effects as compared to treatment with Copaxone® 20 mg/ml administered daily.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Reyna and joined by Judges Bryson and Stoll.

The Federal Circuit reviewed the asserted prior art, and noted that it included:

an understanding that the 20 mg/ml dose had not been optimized

suggestions to explore optimal dosing

recognition that daily injections were problematic for patients

studies of alternate daily dosing of 20 mg/ml

studies of daily dosing of 40 mg/ml (including the “FORTE” study)

studies of alternate daily dosing of 40 mg/ml*

*As noted by the court, this differs from the claimed regimens by one dose over a two week period.

The district court found the claimed regimen obvious based on an “obvious to try rationale” where there was “a finite number of predictable solutions that a person of ordinary skill in the art would have good reason to pursue.” The Federal Circuit affirmed, agreeing that the prior art revealed a motivation to pursue less frequent dosing, a limited number of permutations of dose and frequency to explore, and a reasonable expectation of success because “thrice-weekly 40mg injection would result in a total weekly dose very close to that in the already-approved daily 20mg injection—120mg/week versus 140mg/week.”

In a companion case, the court affirmed the USPTO Patent Trial and Appeal Board Inter Partes Review (IPR) decisions that found three Copaxone patents invalid as obvious.

The “State Of The Art” References

The Federal Circuit decision discusses “two additional references” published after the priority date but nevertheless deemed to be relevant to “the state of the art.”

One was a 2009 study (“Khan 2009”). The Federal Circuit notes that Khan 2009 was “published three weeks after … the priority date of the Copaxone patents, but the study began two years earlier.” The abstract stated, “[t]here is considerable interest in studying a more patient friendly dosing regimen of GA that may be as efficacious and better tolerated than daily GA.” The Khan 2009 study compared 20mg GA 2x/week to 20mg GA daily.

The PTAB’s treatment of Khan 2009 in the IPRs and the Federal Circuit’s comments thereon will be addressed in a separate article.

The other was Teva’s own Phase III trial of the product at issue (40mg GA 3x/week), referred to as “Glatiramer Acetate Low-frequency Administration” (“GALA”). The district court accepted statements in Teva’s FDA submission as an “admission by Teva to inform on the motivations of those having ordinary skill in the art at the time of the invention.” The district court and Federal Circuit cited the following statements to FDA:

[After the FORTE study demonstrated that the 40mg dose was equally effective as the 20mg dose,] the natural next step [was] to reduce the dosing regimen of GA and find the optimal regimen that [would] improve the convenience of treatment and reduce the burden and adverse events associated with daily subcutaneous injections.

[Results of previous studies] demonstrated effects in relapse rate reduction which were comparable to daily injections of GA 20mg, suggesting a lower injection frequency can be considered.

[O]ne may certainly expect a reduction in the frequency of such [side effect] reactions with this new dose regimen, further enhancing subject adherence to treatment.

The Federal Circuit approved the district court’s reliance on these statements as “confirmation of how a POSITA would understand FORTE, which is prior art.”

The courts’ reliance on these post-filing statements to FDA are concerning, because most clinical trial protocols include an explanation of the scientific rationale underlying the study, including a justification for the dose and dosing regimen, and Investigational New Drug Applications must include a summary of previous human trials with the drug and how they relate to “the safety of the proposed investigation or to the investigation’s rationale.” The courts appear to have lost sight of the fact that these explanations were provided by the investigator and informed by hindsight with knowledge of the invention.

I also bristled at the Federal Circuit’s comment that these two references “do not qualify as statutoryprior art”—as if there is some other category of “prior art” that doesn’t quite qualify under the statute but nevertheless can be cited against the novelty or non-obviousness of a patent.

]]>https://www.pharmapatentsblog.com/2018/10/23/invalidity-of-copaxone-patents-supported-by-statements-to-fda/feed/0Don't Touch That Priority Claim!https://www.pharmapatentsblog.com/2018/10/16/dont-touch-that-priority-claim/
https://www.pharmapatentsblog.com/2018/10/16/dont-touch-that-priority-claim/#respondTue, 16 Oct 2018 05:00:20 +0000https://www.pharmapatentsblog.com/?p=7597
In Natural Alternatives Intl. Inc. v. Iancu, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that the patent at issue was not entitled to its earliest claimed priority date because NAI had deleted priority claims in a parent application that broke the priority chain. This decision highlights that a...… Continue reading this entry]]>

In Natural Alternatives Intl. Inc. v. Iancu, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that the patent at issue was not entitled to its earliest claimed priority date because NAI had deleted priority claims in a parent application that broke the priority chain. This decision highlights that a priority claim chain must be continuous and remain unbroken in order for a priority claim to be valid.

The Priority Claim At Issue

The priority claim at issue was made in NAI’s U.S. Patent 8,067,381, which issued from the eighth application in the priority chain shown below.

In 2011, NAI asserted the ‘381 patent against Woodbolt Distributors, LLC, which then requested inter partes reexamination on grounds that included the earliest parent patent (U.S. Patent 5,965,596) as prior art. Woodbolt asserted, and the Patent Office agreed, that the ‘596 patent could be cited against the ‘381 patent because of a defect in the priority chain. In particular, although the priority claim was correctly made in the ‘381 patent, NAI had amended the original priority claim in the fifth application to only claim priority to the 2003 provisional application. Thus, after this amendment, the fifth application no longer contained a “specific reference” to the earlier applications (which included the ‘596 patent) as required by 35 USC § 120.

The Board Decision

In its appeal to the Board, NAI argued that because the sixth application was filed before the priority claims were deleted in the fifth application, those priority claims “vested” as to the sixth and subsequent applications. The Board disagreed, finding instead that by voluntarily deleting the earlier priority claims in the fifth application, NAI had waived priority to the earlier applications. Therefore, all applications claiming priority through the fifth application were not entitled to the benefit of the earlier applications.

NAI appealed the Board decision. Woodbolt was not a party to the appeal, but the Director of the USPTO intervened to defend the Board’s decision.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Prost and joined by Judges Moore and Reyna.

priority to the earlier applications “vested” when a priority claim meeting all criteria of § 120 was made in the sixth application

waiver of priority is limited to the application in which priority is not claimed

priority not “a single growing chain” but “multiple fixed chains”

that the Board’s decision “limits an applicant’s ability to seek protection” when “amending [a] priority claim to gain [patent] term.”

On the first argument, the Federal Circuit found that “NAI’s ‘vesting’ argument conflates properly claiming priority and demonstrating entitlement to priority.” The court focused on practical matters, noting that a priority claim may not be challenged until a court proceeding, that a court “may place the burden on the patent owner to come forward with evidence to prove entitlement … to an earlier filing date, and that “examiners and adjudicators cannot be expected to scrutinize the prosecution history of an application and each parent application to determine whether the application would have met § 120’s requirements at any point during its pendency.”

(In a parallel non-precedential decision, the Federal Circuit upheld the Board decision that the priority claim in U.S. Patent 8,129,422–the seventh application–to be defective for similar reasons, even though the ‘422 patent was filed before the priority claims were deleted in the fifth application.)

On the second argument, the Federal Circuit noted that NAI relied on a specific phrase in the MPEP, reminded that the MPEP does not have the force of law, and found that the MPEP did not support NAI’s position in any event.

On the third argument, the Federal Circuit cited “the long-standing interpretation of priority as a single chain, growing with each additional continuation,” citing the Supreme Court decision in Godfrey v. Eames, 68 U.S. 317, 326 (1863), for the proposition that, under § 120, “parent and continuing applications are to be considered as parts of the same transaction, and both as constituting one continuous application, within the meaning of the law.”

On the fourth argument, the Federal Circuit noted “the trade-off between priority and patent term,” and explained that while it is “permissible” “to disclaim the benefit of earlier filing dates” in order to obtain a longer patent term, “NAI cannot have it both ways.” That is, NAI may not “gain patent term on its fifth application while simultaneously shielding its child applications (including the eighth application) from their former parents.”

The Fragility Of Priority Claims

This decision follows other Federal Circuit decisions highlighting the care that must be taken with making–and preserving–priority claims, especially in long or complex patent families. You can read our articles on other priority claim decisions here.

]]>https://www.pharmapatentsblog.com/2018/10/16/dont-touch-that-priority-claim/feed/0Blocking Patent Discounts Objective Indicia Of Non-Obviousnesshttps://www.pharmapatentsblog.com/2018/10/02/blocking-patent-and-objective-indicia-of-non-obviousness/
https://www.pharmapatentsblog.com/2018/10/02/blocking-patent-and-objective-indicia-of-non-obviousness/#respondTue, 02 Oct 2018 05:00:29 +0000https://www.pharmapatentsblog.com/?p=7559
In Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court decision finding four Acorda Orange Book-listed patents for Ampyra® invalid as obvious. Acorda raised a number of arguments on appeal, but this article focuses on the impact of a blocking patent on consideration of objective indicia of non-obviousness. The Acorda...… Continue reading this entry]]>

In Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court decision finding four Acorda Orange Book-listed patents for Ampyra® invalid as obvious. Acorda raised a number of arguments on appeal, but this article focuses on the impact of a blocking patent on consideration of objective indicia of non-obviousness.

The Acorda Ampyra® Patents At Issue

Ampyra® (4-aminopurine sustained release tablets) is approved for improving walking in patients with multiple sclerosis (MS). The Orange Book-listed patents for Ampyra® include the four Acorda patents at issue in this case—U.S. Patent Nos. 8,007,826, 8,663,685, 8,354,437, and 8,440,703—and an earlier patent licensed from Elan, U.S. Patent No. 5,540,938.

The Elan patent claims methods of treating MS using a sustained release formulation of 4-AP, while the Acorda patents claim additional features including (1) administering a 10 mg dose twice a day; (2) at that stable dose for a treatment period of at least two week; (3) to achieve 4-AP serum levels of 15-35 ng/ml; and (4) to improve walking.

The Underlying ANDA Litigation

This appeal arose from ANDA litigation that involved defendants Roxane, Mylan Pharmaceuticals Inc. and Teva Pharmaceuticals USA, Inc. The defendants stipulated to infringement, but challenged validity. The district court upheld the Elan patent against their obviousness challenge, but found the asserted claims of the Acorda patents obvious. With regard to objective indicia of non-obviousness, the district court acknowledged evidence of commercial success, long felt need, and failure of others, but discounted it because the Elan patent was a “blocking patent” for the claimed methods. That is, because a would-be infringer or generic also would have to invalidate or license the Elan patent, the evidence pertaining to Ampyra® did not show the Acorda patents were non-obvious

The Federal Circuit Decision:

The Impact of Blocking Patents on Objective Indicia of Nonobviousness

The Federal Circuit decision was authored by Judge Taranto. Judge Dyk joined in the decision. Judge Newman filed a dissenting opinion.

On appeal, Acorda argued that the district court improperly “applied a categorical rule that a blocking patent defeats the significance of … objective indicia to the obviousness determination.” The Federal Circuit rejected that characterization, finding instead that the district court had properly considered the impact of the blocking patent “on the limited factual record created in this case.”

The Federal Circuit explained:

A patent has been called a “blocking patent” where practice of a later invention would infringe the earlier patent. The existence of such a blocking patent may deter non-owners and non-licensees from investing the resources needed to make, develop, and market such a later, “blocked” invention, because of the risk of infringement liability and associated monetary or injunctive remedies. If the later invention is eventually patented by an owner or licensee of the blocking patent, that potential deterrent effect is relevant to understanding why others had not made, developed, or marketed that “blocked” invention and, hence, to evaluating objective indicia of the obviousness of the later patent.

The Federal Circuit discussed three previous Federal Circuit decisions discussing blocking patents. In each of Merck & Co. v. Teva Pharmaceuticals USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005) (Merck I), Galderma Laboratories, L.P. v. Tolmar, Inc., 737 F.3d 731 (Fed. Cir. 2013) (Galderma), and Merck Sharp & Dohme Corp. v. Hospira, Inc., 874 F.3d 724 (Fed. Cir. 2017) (Merck II), the earlier (blocking) and later patents were owned by the same entity. In Merck I and Galderma the earlier blocking patents were found to have “depressed incentives for others to invent [the claimed invention]” and “’blocked'” competition. In both cases, evidence of commercial success was discounted in the obviousness analysis because of the blocking patent. In Merck II, the court recognized that “Merck’s exclusive license to a blocking patent did not, all by itself, justify discounting evidence of commercial success” because “commercial success is a ‘fact-specific inquiry.'” But, the judgment of obviousness was affirmed in light of the evidence as a whole.

Citing Merck II, the Federal Circuit explained that “a blocking patent may or may not deter innovation in the blocked space by commercially motivated potential innovators.” The court listed a number of variables in addition to the risk of infringement liability that may be relevant to further innovation, but concluded:

[I]f all other variables are held constant, a blocking patent diminishes possible rewards from a non-owner’s or non-licensee’s investment activity aimed at an invention whose commercial exploitation would be infringing, therefore reducing incentives for innovations in the blocked space by non-owners and non-licensees of the blocking patent. Such a blocking patent therefore can be evidence that can discount the significance of evidence that nobody but the blocking patent’s owners or licensees arrived at, developed, and marketed the invention covered by the later patent at issue in litigation. But the magnitude of the diminution in incentive in any context—in particular, whether it was great enough to have actually deterred activity that otherwise would have occurred—is “a fact-specific inquiry.”

The Impact of the Elan Blocking Patent on Acorda’s Evidence

Turning to the case before it, the Federal Circuit noted that Acorda had exclusively licensed the Elan patent in the late 1990s, which was long before the period of commercial success it alleged for Ampyra®. The Federal Circuit agreed with the district court’s finding that “the risk of infringement liability for marketing in the United States would have provided an independent incentive for a patentee not to develop the invention of the Acorda patents, even if those inventions were obvious.” Acorda argued against any blocking effect because of the safe harbor provisions of 35 U.S.C. § 271(e)(1), but the Federal Circuit commented that the safe harbor, although relevant, does not rule out infringement liability once the product is marketed.

The Federal Circuit agreed with the district court’s treatment of Acorda’s evidence of failure of others and long-felt need for similar reasons, finding that both could be attributed to the blocking effect of the Elan patent.

Judge Newman’s Dissent on Blocking Patents

Judge Newman would have given more weight to the evidence of objective indicia of non-obviousness, and reversed the district court’s judgment that the Acorda patents are invalid as obvious.Judge Newman opined that the majority panel erred in discounting the evidence of objective indicia by incorrectly reasoning that “no one other than the Elan patentees and their licensees could have practiced the invention of the Acorda patents without facing liability for patent infringement.” Judge Newman disagreed with the majority’s blocking patent theory, reasoning that the Elan patent did not block research using AP-4 (because of the safe harbor) or development of other possible treatments, and had not prevented the defendants from developing their generic products.

With respect to long-felt need and failure of others, Judge Newman believed Ampyra® met a long felt need against the backdrop of decades of failed research with 4-AP, including Elan having given up on its work with 4-AP after years of its own research.

Can Objective Indicia Ever Survive A Blocking Patent?

While the Federal Circuit emphasized that the impact of a blocking patent is a “fact-specific inquiry,” it admitted that it is a “difficult one as a practical matter.” The court recognized that “the challengers always retain the burden of persuasion on obviousness,” but surmised that “a court may ultimately be left, for its evaluation, with the solid premise of diminished incentives, plus some evidence (possibly weak or ambiguous) about the significance of the deterrence, together with a background sense of the general realities in the area at issue that can affect the weight to be given to the evidence in the specific case.” Once a district court makes such a “difficult” determination, its factual underpinnings would be entitled to deferential review.

In E.I. DuPont De Nemours & Co. v. Synvina C.V., the Federal Circuit reversed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that had upheld Synvina’s chemical process patent against an obviousness challenge brought in an Inter Partes Review (IPR) proceeding. In so doing, the court outlined four ways to prevail against an obviousness rejection based on routine optimization.

The Patent At Issue

The patent at issue was U.S. Patent No. 8,865,921, directed to methods for preparing 2,5-furan dicarboxylic acid under certain reaction conditions found to overlap with conditions disclosed in three asserted prior art references.

The Federal Circuit Decision:
Overcoming Obviousness Based On Routine Optimization

The Federal Circuit decision was authored by Judge Lourie and joined by Judges O’Malley and Chen.

For decades, this court and its predecessor have recognized that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”

The court also cited In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003), for “[a] more specific application of this general principle”:

A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”

Before addressing the facts before it, the court recognized “several ways by which the patentee may rebut that presumption.”

If the claimed process parameter “produce[s] a new and unexpected result which is different in kind and not merely in degree from the results of the prior art.” (based on Aller)

If the prior art taught away from the claimed range.

If the parameter was not recognized as “result-effective.” (based on In re Applied Materials, Inc., 692 F.3d 1289 (Fed. Cir. 2012))

Turning to the facts before it, the court found that “the presumption of obviousness applies here, and none of the means for rebutting it has been shown.”

The MPEP Only Recognizes Two of the Court’s Four Options

I was interested to see the court outline four options for overcoming an obviousness rejection based on routine optimization, because the current MPEP only recognizes two options. In particular, MPEP § 2144.05 only recognizes these two options:

showing that the range is critical for achieving unexpected results

showing that the prior art teaches away from the claimed paramter(s)

The MPEP used to recognize the third option—showing that the parameter was not recognized as a result-effective variable—but the USPTO removed that option from the current MPEP, apparently believing that it did not survive KSR. On this point, the MPEP states:

In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because “obvious to try” is not a valid rationale for an obviousness finding. In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that “obvious to try” was a valid rationale for an obviousness finding, for example, when there is a “design need” or “market demand” and there are a “finite number” of solutions. …. Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.

Although the court here characterizes this option as a “narrow” exception, it confirmed the underlying principle that “a person of ordinary skill would not always be motivated to optimize a parameter ‘if there is no evidence in the record that the prior art recognized that [that] particular parameter affected the result.’” Thus, the revisions to the MPEP may have gone too far in eliminating this option from MPEP § 2144.05.

The MPEP also does not recognize the fourth option outlined by the court. The guidance on establishing the obviousness of a species when the prior art discloses a genus does instruct examiners to “[c]onsider the size of the prior art genus,” but the discussion focuses on situations where a small genus may support obviousness, not where a large genus does not.

Now that the Federal Circuit plainly outlined four options for overcoming a rejection based on routine optimization, will the USPTO update MPEP § 2144.05?

]]>https://www.pharmapatentsblog.com/2018/09/18/7567/feed/0Sales Catalog From Dealer Trade Show Qualifies As Printed Publicationhttps://www.pharmapatentsblog.com/2018/08/07/7535/
https://www.pharmapatentsblog.com/2018/08/07/7535/#respondTue, 07 Aug 2018 05:00:38 +0000https://www.pharmapatentsblog.com/?p=7535
Petitioners in Inter Partes Review proceedings have looked beyond typical patent and scientific literature to find a “printed publication” that might invalidate a patent. This has given the USPTO Patent Trial and Appeal Board (PTAB) and Federal Circuit an opportunity to explain and further define that category of prior art. GoPro, Inc. v. Contour IP...… Continue reading this entry]]>

Petitioners in Inter Partes Review proceedings have looked beyond typical patent and scientific literature to find a “printed publication” that might invalidate a patent. This has given the USPTO Patent Trial and Appeal Board (PTAB) and Federal Circuit an opportunity to explain and further define that category of prior art. GoPro, Inc. v. Contour IP Holding LLC is the latest Federal Circuit decision in this category. There, the court reversed the PTAB and found that a sports video camera sales catalog distributed at an action sports vehicle dealer trade show qualified as a “printed publication” under 35 USC § 102.

The Patents At Issue

GoPro petitioned for Inter Partes Review of two Contour patents (U.S. Patent Nos. 8,890,954 and 8,896,694) directed to “action sport video cameras” that are “configured for remote image acquisition control and viewing.” The PTAB’s Institution Decision found that “a person of ordinary skill in the art would have had at least a bachelor’s degree in computer science, electrical engineering, or a similar discipline, and some experience creating, programming, or working with digital video cameras, such as point of view (“POV”) action sports video cameras.”

GoPro cited one of its own sales catalogs as a primary reference. The catalog had been distributed at a dealer trade show put on by a trade organization said to be “focused on action sports vehicles as well as related apparel, parts, and accessories.” GoPro submitted a declaration providing testimony that “at the 2009 [trade] show, there were approximately 150 vendors and more than 1,000 attendees, including actual and potential dealers, retailers, and customers of portable POV video cameras.” The declaration included testimony that the GoPro Catalog was actually distributed to attendees, and also was “available to GoPro’s actual and potential customers, dealers, and retailers through its website, direct mail, and other means of distribution” after the trade show.”

The PTAB Decision

The PTAB’s Final Written Decision found that GoPro had not demonstrated that the challenged claims were unpatentable, because it had not demonstrated that the GoPro Catalog qualified as a printed publication.

Contour had challenged the qualifications of the GoPro Catalog in its Patent Owner Response, citing evidence that the trade show was not open to the general public. The PTAB was convinced by that argument.

Specifically, the PTAB found that a person of ordinary skill in the art “would not be interested in the dealer show because it was not an academic conference or camera industry conference, but rather a dealer show for action sports vehicles like motorcycles, motorbikes, ATVs, snowmobiles, and watercraft.” Thus, the PTAB determined that the catalog did not qualify as a printed publication, because “GoPro had not met its burden to show that the GoPro Catalog was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art and exercising reasonable diligence could have located it.”

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Reyna and joined by Judges Wallach and Hughes.

The court determined that the PTAB had applied the “printed publication” requirement for “accessibility” too narrowly. The PTAB had focused on the expertise of the target audience of the trade show, but the court emphasized that is only one factor to be considered:

[O]ur case law directs us to also consider the nature of the conference or meeting; whether there are restrictions on public disclosure of the information; expectations of confidentiality; and expectations of sharing the information.

With regard to trade shows in particular, the court noted:

Trade shows are not unlike conferences—a trade show is directed to individuals interested in the commercial and developmental aspects of products.

Turning to the facts before it, the court found:

The fact that the dealer trade show was focused on action sports vehicles is not determinative, especially since the patents indicate that “a primary purpose of POV cameras is for use on vehicles in extreme action environments,” such as the ones promoted at the trade show.

Although the trade show was only open to dealers, “it is more likely than not that persons ordinarily skilled and interested in POV a cameras were in attendance or at least knew about the trade show and expected to find action sports cameras at the show.”

“[T]he GoPro Catalog was disseminated with no restrictions and was intended to reach the general public.”

The court concluded that the relevant audience of persons ordinarily skilled and interested in POV action cameras “exercising reasonable diligence, should have been aware of the show,” such that the GoPro Catalog satisfied the legal standard for public accessibility.

The court thus found that GoPro indeed had “met its burden to show that its catalog is a printed publication under § 102(b),” and remanded to the PTAB to consider GoPro’s obviousness claims on the merits.

Questions Raised By The GoPro Decision

The GoPro decision raises at least two questions. First, do USPTO examiners conduct the type of searches that might identify sales catalogs distributed at trade shows years before an application was filed, or is this type of prior art only going to be identified by competitors? Second, did the Federal Circuit make new findings of fact as to the trade show audience in reaching its decision?

In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit affirmed decisions of the Patent Trial and Appeal Board (PTAB) that invalidated seven Orange Book-listed patents for Xyrem®. The main issue on appeal was whether FDA meeting materials available on a web page published in a Federal Register Notice qualified as a “printed publication” under 35 USC § 102. The Federal Circuit agreed with the PTAB that they did.

The Xyrem® Patents At Issue

Xyrem® is approved for the treatment of symptoms associated with narcolepsy, but its active ingredient (gamma-hydroxybutyrate) also is known as the “date-rape drug.” As noted in the Federal Circuit decision, “[b]ecause of its potential for abuse, the FDA approved Xyrem® under ‘restricted distribution regulations … to assure safe use of the product.” The seven Jazz’ patents at issue (U.S. Patent Nos. 7,668,730; 7,765,106; 7,765,107; 7,895,059; 8,589,182; 8,457,988; and 8,731,963) relate to methods of distributing a prescription drug that is under the exclusive control of an exclusive central pharmacy that involves verifying the credentials of the prescribing doctor and screening for potential abuse.

The Advisory Committee Art

The prior art at issue was four documents associated with a public meeting of the FDA advisory committee for Xyrem®: “(1) the FDA advisory committee meeting transcript and slides; (2) an FDA preliminary clinical safety review of Xyrem®; (3) a Xyrem® briefing booklet; and (4) a video and transcript regarding a proposed distribution system for Xyrem®.” The PTAB determined that the ACA materials were publicly accessible on an FDA website no later than October 4, 2001, which was prior to the critical date of December 17, 2001. The FDA website was publicized in a May 14, 2001 Federal Register Notice that announced the meeting.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Lourie and joined by Judges Newman and Reyna.

In its summary of the applicable law, the Federal Circuit emphasized “public accessibility” as the “touchstone in determining whether a reference constitutes a ‘printed publication.'” As to “public accessibility,” the court noted:

A reference is considered publicly accessible upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.

The court noted further:

If accessibility is proved, there is no requirement to show that particular members of the public actually received the information.

In finding the meeting materials qualified as printed publications the court noted:

the breadth of the dissemination:
“[T]he Notice in the Federal Register widely disseminated the ACA materials through a hyperlink to a public FDA website where the ACA materials could be accessed. The Notice explained what materials were located on the FDA website, approximately when they would be available, and how to navigate to them.”

the disseminated material was addressed to or of interest to persons of ordinary skill in the art:
“The Board found, unchallenged on appeal, that a person of ordinary skill ‘would have been familiar with the Federal Register and motivated to look for notices related to drug distribution, safety, or abuse prevention.'”

the materials “were available online for a substantial time before the critical date”

the materials “were distributed via public domain sources with no possible expectation that the materials would remain confidential or not be copied”

The Federal Circuit rejected Jazz’s argument that “indexing or searchability” were legally required “for a reference to be a printed publication under § 102(b),” but also found that the Federal Register was adequately indexed.

As we have explained, the ACA materials were publicly accessible because they were broadly disseminated to interested persons of ordinary skill for a substantial time with no expectations of confidentiality. The Board did not need to find that specific persons actually received or examined the materials.

Scientific Meetings Versus Agency Meetings

In reaching its decision, the Federal Circuit noted that “[t]his is not the first time we have considered whether materials disclosed in association with meetings or conferences were ‘printed publications.” However, the court’s previous decisions related to scientific meetings, not meetings of a Federal agency. That said, perhaps the “person of ordinary skill in the art” for these patents would have been particularly interested in FDA meetings and motivated to keep up with FDA activity by monitoring the Federal Register. Or perhaps interest in the Federal Register is another fictitious characteristic of the “person of ordinary skill” in this particular art.

]]>https://www.pharmapatentsblog.com/2018/07/31/meeting-materials-cited-in-federal-register-notice-qualify-as-printed-publication/feed/0CAFC Finds Publication Did Not Inherently Disclose Aveed Compositionhttps://www.pharmapatentsblog.com/2018/07/24/cafc-finds-publication-did-not-inherently-disclose-aveed-composition/
https://www.pharmapatentsblog.com/2018/07/24/cafc-finds-publication-did-not-inherently-disclose-aveed-composition/#respondTue, 24 Jul 2018 05:00:58 +0000https://www.pharmapatentsblog.com/?p=7521
In Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., the Federal Circuit affirmed the district court’s finding that two patents listed in the Orange Book for Aveed® had not been shown to be obvious. Although prior art disclosed clinical studies that used the formulation, the Federal Circuit agreed the disclosures were not sufficient for inherency-based invalidity....… Continue reading this entry]]>

In Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., the Federal Circuit affirmed the district court’s finding that two patents listed in the Orange Book for Aveed® had not been shown to be obvious. Although prior art disclosed clinical studies that used the formulation, the Federal Circuit agreed the disclosures were not sufficient for inherency-based invalidity. This decision provides an illustrative reminder of the difference between prior art challenges based on a prior art publication versus a prior use.

The Aveed® Patents at Issue

The Aveed® patents at issue were Bayer’s U.S. 7,718,640 and U.S. 8,338,395. (Endo Pharmaceuticals Solutions holds the approved NDA for Aveed®). Aveed® is a long-acting testosterone replacement therapy for physiologically low levels of testosterone, known as hypogonadism. The patented formulation is said to require only five injections a year, work for nearly all hypogonadism patients, and avoid testosterone fluctuations associated with previous injectable testosterone therapies.

Claim 2 of the ’640 patent was asserted in the litigation. Claims 1 and 2 recite:

1. A composition formulated for intramuscular injection in a form for single injection which contains 250 mg/ml testosterone undecanoate in a vehicle containing a mixture ofcastor oil and benzyl benzoate wherein the vehicle contains castor oil in a concentration of 40 to 42 vol %.

2. A composition formulated for intramuscular injection in a form for single injection according to claim 1, which contains 750 mg testosterone undecanoate.

Claim 18 of the ’395 patent also was asserted. Claims 14 and 18 recites:

14. A method of treating a disease or symptom associated with deficient endogenous levels of testosterone in a man, comprising administering by intramuscular injection a composition comprising testosterone undecanoate (TU) and a vehicle consisting essentially of castor oil and a cosolvent, the castor oil being present in the vehicle at a concentration of 42 percent or less by volume, the method further comprising:
(i) an initial phase comprising 2 initial intramuscular injections of a dose of TU at an interval of 4 weeks between injections, each dose including 500 mg to 1000 mg of TU, followed by,
(ii) a maintenance phase comprising subsequent intramuscular injections of a dose of TU at an interval of 10 weeks between injections, each dose including 500 mg to 1000 mg of TU.

18. The method of claim 14, in which each dose contains 750 mg of TU.

The District Court Proceeding

Endo and Bayer brought an infringement action against Custopharm in response to the latter’s submission of an ANDA to the FDA for approval to market a generic version of Aveed®, which included a Paragraph IV certification. In the district court, Custopharm stipulated to infringement, and Endo and Bayer limited their asserted claims to claim 2 of the ’640 patent and claim 18 of the ’395 patent. The resulting bench trial concerned invalidity of those claims. The district court concluded that Custopharm had not proven invalidity under § 103.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Chen and joined by Judges Moore and Linn.

A key issue on appeal was the district court’s finding that the vehicle formulation—40% castor oil and 60% benzyl benzoate—was not inherently described in prior art articles describing the clinical studies. Custopharm had argued that this formulation was “necessarily present” in the prior art because, as later revealed, the authors—one of whom overlapped with the inventorship of the patent at issue—had actually used it in their studies. The Federal Circuit disagreed.

In particular, Custopharm argued that the vehicle formulation was inherently disclosed through the detailed pharmacokinetic data reported in the articles, from which—according to Custopharm—”a skilled artisan could derive that the vehicle consisted of 40% castor oil and 60% benzyl benzoate.” The district court had determined that information was not enough “to establish that the Articles barred the possibility of an alternative vehicle being used in the prior art compositions,” as required to “meet the rigorous standard of inherency.”

The Federal Circuit agreed that Custopharm had not demonstrated that a skilled artisan could extrapolate the vehicle formulation from the pharmacokinetic data, and noted that Custopharm had improperly tried to shift the burden to the patent owner on this point:

Custopharm’s own opening brief does not argue that the pharmacokinetic performance reported in the Articles can only be attributed to the claimed vehicle formulation. Moreover, Custopharm’s brief incorrectly shifts the burden of proof to Endo and Bayer. Custopharm argues that . . . Endo and Bayer’s pharmacokinetic expert, failed to provide any evidence to support his view that “it was possible to have the same pharmacokinetic profile with two different formulations.” But, it is Custopharm’s burden to present clear and convincing evidence that the Articles necessarily disclosed the vehicle formulation to one of skill in the art.

The Federal Circuit also observed that a skilled artisan would not have necessarily recognized that the study authors had used benzyl benzoate as a cosolvent, given the abundance of other potential cosolvents:

Endo and Bayer’s expert testified that, based on the Articles’ disclosures, a skilled artisan would not have recognized that a co-solvent was necessary. And even if a skilled artisan concluded that a co-solvent was necessary, there were any number of available co-solvents, including, for example, benzyl alcohol, ethanol, cottonseed oil, sesame oil, peanut oil, corn oil, fractionated coconut oil, ethyl lactate, ethyl oleate, and isopropyl myristate. Moreover, Custopharm’s expert conceded that even knowing the identity of the cosolvent would not necessarily lead a skilled artisan to the particular ratio claimed in the ’650 and ’395 patents.

The Federal Circuit distinguished this case from inherency cases where the prior art had described a knownproduct:

Importantly, Crish and Omeprazole were about inherently present properties or characteristics for a “known” prior art product. But here, the TU injection composition recounted in the Articles cannot be said to be “known” in the same way; the Articles failed to disclose that the composition’s vehicle formulation included another, key ingredient, benzyl benzoate, let alone the ratio of benzyl benzoate to castor oil. And there was no evidence in the record that a skilled artisan could determine the non-disclosed vehicle formulation based on the reported pharmacokinetic performance profile, or that the non-disclosed vehicle formulation was necessarily a feature of the TU injection studied in the Articles.

The Federal Circuit concluded:

[T]he incomplete description of the TU injection composition elements denied skilled artisans from having access to that composition, thereby precluding use of the inherency doctrine to fill in disclosure about the product missing from the Articles.

Inherency and “Necessarily Present” Limitations

While the “necessarily present” requirement of the inherency doctrine is well-settled, this decision highlights important factors in an inherency analysis. First, this case illustrates that when the product at issue is not known in the prior art, there must be evidence that the non-disclosed features would necessarily be present. Second, this case provides a reminder of the difference between invoking the doctrine with reference to a prior art publication, where the inquiry focuses on what was disclosed, and invoking the doctrine with reference to prior art public use, where the inquiry would concern what actually was used.